Kornimate/medical-research-clean huggingface dataset:
gnrh agonist (gnrha) withdrawal at late stage of long protocol and the incidence of ovarian hyper-stimulation

Conditions: Infertile High-risk Patients With Polycystic Ovaries

Summary: to test whether gnrha withheld 2-3 days before ovulation trigger reduces the incidence of ovarian hyperstimulation syndrome (ohss) in infertile high-risk patients with polycystic ovaries (pcos) who have been treated with gonadotropins for in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi).

all the patients received a midluteal long gnrh agonist (gnrh-a) and a gonadotropins (recombinant fsh) stimulation protocol. pituitary down-regulation with gnrh agonist (triptorelin, 0.1mg/d, ×10d, then 0.05mg/d until e2 ≤40 pg/ml in serum), was initiated during the luteal phase on the cycle-day 21. two weeks later, if e2 in serum was ≤40 pg/ml and absence of follicular activity was detected, the stimulation of ovaries was started by recombinant follicle-stimulating hormone (recfsh, gonal-f, serono, switzerland) with doses ranging 150-250 iu/d. doses were adjusted accordingly with ovarian monitoring and follicles growth. gnrha (0.05mg/d) was injected stimulously with fsh before dominant follicles were ≥ 14 mm. when the diameter of one or more follicles was ≥ 14 mm, gnrha (0.05mg/d) was withheld in the study group. in the control group, gnrha was used to the day of ovulation trigger. ovulation was induced with hcg (5000-10000 iu) when at least three follicles greater than 16mm in diameter were detected on ultrasound examination and the leading follicles reached ≥ 18 mm in diameter. oocytes retrieval for ivf or icsi was performed 34-36 hours later under transvaginal ultrasound guidance. main outcome measure(s): serum e2 levels, vegf levels in serum and follicular fluids, retrieved oocytes, fertilization, implantation rate and pregnancy rate (pr), the rate of ohss.

Eligibility criteria:
inclusion criteria: ninety-six infertile patients with pcos (12 or more follicles 2-9 mm in diameter were detected in ovaries by ultrasound detection) undergoing ivf treatment were enrolled. exclusion criteria: the subjects included the followings: a basal fsh level of \> 10iu/l; age \>35 years; a body mass index (bmi) \> 30 kg/m2; ovarian surgery radiotherapy or chemotherapy; ovarian dysfunction; endometriosis; hyperprolactinemia; thyroid dysfunction; the presence of organic pelvic diseases.

Keywords: gnrh agonist withdrawal ohss e2 vegf
combined dietary education of low sodium and high potassium consumption

Conditions: Prehypertension; Hypertension

Summary: reduction in sodium consumption is important approach in public health care. in general population, reduction of sodium intake can reduce the future development of hypertension and cardiovascular event. meanwhile, enhancement of potassium consumption is also important to reduce blood pressure and cardiovascular events. we hypothesized that combined education of low sodium and high potassium consumption is more effective in reducing blood pressure compared to dietary education of low sodium consumption only. the present survey study was designed to test the effectiveness of combined education of low sodium and high potassium consumption in blood pressure reduction and improvement of other variables.


Eligibility criteria:
inclusion criteria: 1. prehypertension: with a systolic pressure from 120 to 139 mm hg or a diastolic pressure from 80 to 89 mm hg 2. stage 1 hypertension: with a systolic pressure from 140 to 159 mm hg or a diastolic pressure from 90 to 99 mm hg exclusion criteria: 1. urinary tract disease 2. secondary hypertension 3. previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months 4. ventricular tachycardia, atrial fibrillation and flutter 5. hypertrophic cardiomyopathy 6. known chronic kidney disease: serum creatinine = or \> 2.0 mg/dl 7. hypokalemia (\ 5.5 mmol/l) 8. type 1 diabetes mellitus 9. poorly controlled diabetes mellitus (hba1c = or \> 9%) 10. unable to collect 24 hour urine sample 11. pregnancy 12. alcoholics 13. severe liver disease 14. night workers 15. mental retardation

Keywords: prehypertension hypertension sodium potassium renin aldosterone
a multi-center clinical longitudinal study of neuropathic pain by collecting data

Conditions: Pain

Summary: a multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function

using the use of pain visual analog scale (vas), digital pain grading method (nrs), neuropathic pain assessment scale (dn4), sleep quality (pittsburgh sleep quality index, ascens insomnia scale), social support assessment scale (ssq), montreal cognitive assessment scale (moca), barrett impulse scale (bis), anxiety and depression score (gad-7, phq-9), emotional tasks, cognitive function (n-back, time perception, delay-discount), electroencephalogram (eeg), near-infrared brain function imaging (fnirs) and other indicators to study the dynamic changes of various factors in the process of acute pain.

Eligibility criteria:
inclusion criteria: 1. the subjects voluntarily participated in the study and signed an informed consent form; 2. the age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender; 3. body mass index (bmi) ≤ 45; 4. clinically clearly diagnosed neuropathological pain (pain vas score ≥4 or above); 5. did not participate in the drug/medical device test within 3 months before the test; exclusion criteria: -
effect of low-carbohydrate/high-fat diet on glucose tolerance and lipid profile in lean, healthy women

Conditions: Insulin Sensitivity; Weight

Summary: intervention studying the effect of a low-carbohydrate/high-fat (lchf) diet as well as on bout of exercise in combination with either a normal diet or a lchf diet, in relation to glucose metabolism, insulin sensitivity, lipid profile and body composition.


Eligibility criteria:
inclusion criteria: * females * normal weight * bmi between 18.5 and 25 * moderately trained exclusion criteria: * smokers/tobacco users * pregnancy * familial cardio-vascular-disease * diabetes or reduced glucose tolerance * under- or overweight (bmi under 18.5 or over 25) * top athletes

Keywords: insulin sensitivity lipid profile body composition weight
stem cell therapy in spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.

autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

Eligibility criteria:
inclusion criteria: * diagnosed cases of any type of spinal cord injury * age above 12 months. exclusion criteria: * presence of acute infections such as human immunodeficiency virus/hepatitis b virus/hepatitis c virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia.

Keywords: spinal cord injury stem cell therapy bone marrow mononuclear cells autologous
bipolar transcranial alternating current stimulation (tacs)

Conditions: Bipolar Disorder

Summary: the purpose of this clinical trial is to measure the safety and effectiveness of a non-invasive brain stimulation device called transcranial alternating current stimulation (tacs) in participants with bipolar disorder (bd). participants will be asked to come in for 3 sessions. if participants qualify at the screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well as have a 30-day follow-up phone call.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of bd based on diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria being met from previous enrollment in the prechter bipolar longitudinal study * this study will select bd patients that scored above published norms (upper 50th percentile) on the neo-pi impulsivity facet to ensure that the recruited patients exhibit the network dysfunction targeted by the tacs paradigm and therefore have the potential to benefit from this neuromodulation technique. * patients must be on a stable dose of medication for two weeks prior to sessions 2 and 3. exclusion criteria: * significant neurological abnormalities, such as seizure disorder, mass lesions, etc. * known mendelian disorder * active problematic substance use in the past 30 days (as determined by the substance use disorder module of scid) * evidence of suicidal intentions or behaviors in the past month, as judged by affirmative responses to question number 4 or number 5 on the columbia suicide severity rating scale (cssrs) or report of suicidal behaviors in the last 6 months * pregnant or trying to become pregnant, or currently lactating.

Keywords: transcranial alternating current stimulation (tacs) electroencephalogram (eeg)
long term study of valsartan and amlodipine in patients with essential hypertension (extension to study cvaa489a1301)

Conditions: Hypertension

Summary: the purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of valsartan and amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * patients who successfully complete the core study (study cvaa489a1301. * patients whose blood pressure at visit 7 of the study cvaa489a1301 had to be well controlled defined as msdbp \< 90 mmhg and mssbp \< 140 mmhg. at the investigator's or sub-investigator's discretion, those patients who were not well controlled (msdbp ≥ 90 mmhg or mssbp ≥ 140 mmhg), and whose msdbp was \< 100 mmhg and mssbp was \< 160 mmhg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient. * male or female outpatients. * patients who have written informed consent to participate in this study. exclusion criteria: * presence of major protocol violation in study cvaa489a1301. * patients who experienced any adverse events considered serious and drug related in study cvaa489a1301. * patients who experienced any adverse events considered serious and drug related in study cvaa489a1301. * patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator. * patients who have gout or gouty arthritis. * patients hypersensitive to diuretics (except for potassium sparing diuretics). other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, valsartan, amlodipine, high blood pressure
dexmedetomidine as an intrathecal adjuvant to hyperbaric bupivacaine for postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgeries

Conditions: Dexmedetomidine; Intrathecal; Adjuvant; Hyperbaric Bupivacaine; Analgesia; Arthroscopic Anterior Cruciate Ligament Reconstruction

Summary: this study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in arthroscopic anterior cruciate ligament reconstruction surgeries

the anterior cruciate ligament (acl) is injured frequently during sports participation. arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of acl injury. postoperative pain should be effectively treated because it represents an important component of postoperative recovery. effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity. dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. it reduces opioid and inhalational anesthetics requirements.

Eligibility criteria:
inclusion criteria: * aged from 21 to 50 years. * both genders. * american society of anesthesiologists (asa) physical status i and ii. * patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia. exclusion criteria: * patient refusal. * body mass index (bmi) more than 40 kg/m2. * patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse. * uncooperative patient. * patients with coagulation disorders. * history of local anesthetics allergy. * infection at the needle puncture site. * patients with significant respiratory, cardiac, renal or hepatic disorders
a study to evaluate the safety and efficacy of pac-14028 cream in skin pruritus

Conditions: Skin Pruritus

Summary: the study is a phase ii, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. all subjects will receive bid topical applications of pac-14028 cream or vehicle for up to 4 weeks.


Eligibility criteria:
inclusion criteria: * male and female patients aged 19 - 70 years * patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg) * patients whose result of the pruritus test (visual analogue scale, vas) at visit 1 and 2 is 5 or more * patients whose overall dry skin score of the area where investigational product is applied at visit 1 and 2 is 2 points or more exclusion criteria: * patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease * patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases * patients with simple pruritus caused by such allergic material as scabies, and insect bite wound * patients with the symptom of systemic infection at the time of the participation in the clinical study * patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks * patients with a history of taking oral steroid agent within 4 weeks * patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks * pregnant or breast-feeding women * women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period
islet transplantation through an indwelling catheter in the umbilical vein

Conditions: Type 1 Diabetes Mellitus

Summary: islet transplantation is one of the effective and promising options for type 1 diabetes mellitus treatment1-4. the liver is the primary target location for infusion and portal vein catheterization is generally used. percutaneous transjugular, percutaneous transhepatic, laparoscopically transmesenteric and laparoscopically transumbilical approaches were often utilized to access the portal. current islet infusion approach via portal vein of liver has various defects. percutaneous trans-hepatic puncture is risk of possible severe hemorrhage and portal thrombosis. the laparoscopic entry techniques require longer surgical duration and have an increased rate of catheterization failure. moreover, the catheters were not allowed to indwell for subsequent infusions. in the current study, the investigators aim to performed open surgery, catheterized the umbilical vein and infused islets into the portal vein. the catheter was indwelled for one month after surgery. therapeutic effects, surgical parameters and complications were observed to evaluate feasibility and safety.


Eligibility criteria:
inclusion criteria: * male and female patients age 18 to 60 years of age. * ability to provide written informed consent. * clinical history compatible with type 1 diabetes (t1dm) as defined by the who guidelines(2007) on the diagnosis and classification of diabetes mellitus. * manifest signs and symptoms that are severe enough to be incapacitating. * basal c-peptide\<0.5ng/ml * patients with poor diabetes control (hba1c \>7% but \<12%) * progressive diabetic complications. exclusion criteria: * age \ 60 years * diabetic history \<5 years * bmi\>27 * body weight \>80kg * exogenous insulin requirement \>1 unit/kg/day * severe anemia (male \<8g/dl, female \<7g/dl) * low white blood cell count (\<3000/dl) * liver dysfunction * symptomatic peptic ulcer disease * any malignancy * active infection including hepatitis b, hepatitis c, hiv, or tb * panel reactive antibody \>20% * any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
carnitine levels and carnitine supplementation in type i diabetes

Conditions: Diabetes Mellitus, Type I; Hypoglycemia

Summary: the purpose of this study is to determine whether type i diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. if they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.

hypoglycemia is a clinical marker of carnitine deficiency. thus carnitine may compound the risk of hypoglycemia for children on insulin therapy. currently, one of the limitations in the management of diabetes is hypoglycemia. the problem of hypoglycemia is of even greater significance in the pediatric population because children have smaller glycogen stores. in this study, we will determine if there is a group of children with increased frequency of hypoglycemia and carnitine deficiency. if there is a correlation from the initial 200 children, we will compare two groups of type i diabetic children between the ages of 7 to 21 years. we will take 20 children with the highest carnitine levels (found in a previous study) and 20 children with the lowest carnitine levels and perform continuous glucose monitoring for a 72-hour period. those who have at least one episode of hypoglycemia will be asked to undergo repeat testing, after a 2-week period of oral carnitine supplementation. supplementation will start at 50 mg/kg body weight for the first week and then increase to 100 mg/kg body weight the second week. laboratory studies obtained at baseline include hemoglobin a1c, carnitine panel, and lipid panel. these will be repeated prior to the second continuous glucose monitoring. insulin doses will not be changed between glucose monitoring sessions. a comparison will be made between individuals with hypoglycemia, to see if the number of hypoglycemic events has decreased.

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type i for greater than 2 years between the ages of 7 and 21 * currently on insulin replacement therapy exclusion criteria: * patients with newly diagnosed type i diabetes * patients already taking l-carnitine * patients who come to clinic without glucose monitors * patients with known seizure disorders not including hypoglycemic seizures * patients on metformin * patients with compromised renal function.

Keywords: diabetes mellitus type i, hypoglycemia, carnitine
nicotine vaccination and nicotinic receptor occupancy

Conditions: Nicotine Dependence

Summary: this is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with nicvax, a nicotine vaccine developed by nabi biopharmaceuticals. nicvax (nicotine conjugate vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker. in this project we want to understand the degree to which nicvax administration changes how much nicotine enters the brain in smokers.

the purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nachr) by nicotine both at baseline and following administration of a nicotine vaccine. the number of brain β2-nachr and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist \[123i\]5-ia-85380 (\[123i\]5-ia) and single photon emission computed tomography (spect). \[123i\]5-ia will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). three baseline spect images will be obtained after equilibrium has been reached (\~6 hours into the \[123i\]5-ia infusion). then, iv nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second \[123i\]5-ia scan day. we hypothesize that occupancy of β2-nachr will be significantly lower, and take longer to plateau, following nicotine vaccine administration.

Eligibility criteria:
inclusion criteria: * current smoker who smokes at least 10-25 cigarettes a day * good general health exclusion criteria: * subjects with a pacemaker or other ferromagnetic material in body. * prior exposure to nicvax or any other nicotine vaccine. * use of systemic steroids or other immunosuppressive agent * history of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness * cancer or cancer treatment in last 5 years * hiv infection * use of varenicline (chantix), bupropion (wellbutrin, zyban), mecamylamine (inversin), within 30 days prior to administration of nicvax and for the duration of the study. * inability to fulfill all visits and examination procedures for approximately 20 weeks.

Keywords: nicotine, spect, vaccine, receptor